Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgG II For ARCHITECT i System 100 Tests 6.6 mL Microparticles, 5.9 mL Conjugate, 7.9 mL Diluent06S6020
Picture of Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgG II For ARCHITECT i System 100 Tests 6.6 mL Microparticles, 5.9 mL Conjugate, 7.9 mL Diluent06S6020

Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgG II For ARCHITECT i System 100 Tests 6.6 mL Microparticles, 5.9 mL Conjugate, 7.9 mL Diluent06S6020

Reagent-Kit-AdviseDx-Antibody-Test-SARS-CoV-2-IgG-II-For-ARCHITECT-i-System-100-Tests-6-6-mL-Microparticles,-5-9-mL-Conjugate,-7-9-mL-Diluent06S6020

SKU #

#1187915

MPN #

06S6020

Brand

Abbott

Stock

In Stock

Quantity

100

Features

REAGENT, SARS-COV-2 IGG II ALINITY ADVISE DX (100TEST/KT)D/S

$750.00 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1187915
Manufacturer # 06S6020
Brand AdviseDx
Manufacturer Abbott
Application Reagent Kit
Container Type Cartridge
For Use With For ARCHITECT i System
Number of Tests 100 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Sample Type Human Serum / Plasma Sample
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 IgG II
Test Type Antibody Test
Type Chemiluminescent Microparticle Immunoassay (CMIA)
UNSPSC Code 41116020
Volume 6.6 mL Microparticles, 5.9 mL Conjugate, 7.9 mL Diluent
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  • The AdviseDx SARS-CoV-2 IgG II assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • The AdviseDx SARS-CoV-2 IgG II assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma on the ARCHITECT i System using serum, serum separator, acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator, and sodium heparin tubes
  • At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
  • The AdviseDx SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection
  • Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
  • False positive results for the AdviseDx SARS-CoV-2 IgG II assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgG assay